ROOM LEAD, PACKAGING

POSITION SUMMARY:

The Kansas City Clinical Supply Services Room Lead supports clinical trial projects through the packaging of clinical trial supplies, ensuring work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). The Clinical Supply Services Room Lead is key to ensuring the quality of outputs, adherence to the production schedule, and delegation of job-specific tasks. This position oversees the execution of all clinical and commercial batch records in primary, secondary and the potent packaging areas. This position reports to the Production Supervisor but will also receive instruction from the Clinical Supply Services Team Lead.

CATALENT IS COMMITTED TO A PATIENT FIRST CULTURE THROUGH EXCELLENCE IN QUALITY AND COMPLIANCE, AND TO THE SAFETY OF EVERY PATIENT, CONSUMER AND CATALENT EMPLOYEE.

MONDAY-FRIDAY:

2:30PM-11:00PM

SIGN ON BONUS:

$1,500

THE ROLE:

• Ensure that during all packaging operations the site's safety, quality and compliance metrics are met or surpassed as well as corporate metrics
• Will lead assigned team members and work alongside them to successfully complete clinical trial and commercial packaging jobs on a daily basis, effectively delegate tasks and ensure completion
• Responsible for the safety, quality, delivery and cost (SQDC) of all clinical and commercial outputs
• Understand, interpret, and communicate organizational metrics and goals and lead assigned team members to consistently reach team and organizational goals, assess operator strengths and weaknesses and leverage this information when assigning tasks during batch execution
• Must be able to successfully manage competing priorities and personalities, create a positive work environment for operators with effective people leadership
• Ensure accurate entries are made into the batch record consistently and on time, adhere to cGMP and GDP when completing and reviewing production batch records and alert management of any potential deviations or infractions in a timely manner
• Ensure that the production room is set up to ensure efficiently produced, high-quality outputs and troubleshoot downtime in production rooms
• May be required to oversee multiple on-going production operations
• Understands and enforces GMP gowning and de-gowning requirements for each production area (primary, secondary and potent packaging suites)
• Other duties as assigned

THE CANDIDATE:

• High School degree or equivalent
• A minimum of 2 year's of clinical trial packaging experience or related manufacturing/operations experience preferred. Demonstrated ability to motivate and lead others while working alongside them to complete tasks to reach organizational goals.
• Position requires ability to spend extended periods of time in the following GMP environments: Controlled Room Temperature 68 degrees F - 77 degrees F (20 degrees C - 25 degrees C), Refrigerator 35 degrees F - 46 degrees F (2 degrees C - 8 degrees C), Freezer -4 degrees F (-20 degrees C), Highly active containment area (Potent Drug Facility) (respirator fit testing and pulmonary physical required)
• Handling of controlled substance product - a background check and further DEA screening is required

WHY YOU SHOULD JOIN CATALENT:

• Competitive medical benefits and 401K
• 19 days of PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment

CATALENT OFFERS REWARDING OPPORTUNITIES TO FURTHER YOUR CAREER!

Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives:

Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

Catalent is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. We have built an advanced range of technologies and capabilities and are dedicated to enabling a better and faster customer journey from product development directly to patient. At Catalent, we share a common goal, to put patients first and help people around the world live better and healthier lives.